Remotely controlled bilateral alternating tactile stimulation  therapeutic method and system

ABSTRACT

A bilateral alternating tactile stimulation therapeutic system includes an Internet web page; a first mobile device, at a first location, configured to access the Internet web page, wherein the first mobile device has a first application for transmitting audio information and pulse control information including alternating pulsation signals for uploading to the Internet web page; a second mobile device, at a second location remote from the first location, adapted to connect to the Internet web page and having a second application for receiving the audio information and the pulse control information in a streaming or live mode; a pair of pulsating devices wirelessly coupled to the second mobile device; and wherein the second mobile device is programmed to enable a subject to hear the audio information and also transmit the alternating pulsation signals to the pair of pulsating devices.

TECHNICAL FIELD

The present invention relates to a method and system for providingtactile bilateral stimulation therapy. More particularly, the method andsystem are directed to providing a remote control internet accessibletactile bilateral stimulation therapy system operated by a therapist orusing a therapy program recorded by a therapist.

BACKGROUND

Therapy sessions with PTSD clients often benefit from using a specifictechnology to stimulate the bilateral access required in order to getthe traumatic memories moving. The same technology is used to restoreequilibrium and allow the client to center themselves creating a senseof internal safety. One limitation of the existing technology when usedby a therapist, is that it most often requires the client and therapistto be in the same room.

Anxiety disorders are the most common mental disorders in the UnitedStates, resulting in very large health care costs in addition toconsiderable disease burden; studies show that up to 33.7% of thepopulation is affected by an anxiety disorder at some point in theirlifetime (Bandelow and Michaelis 2015). Bilateral stimulation therapy(BLS) is a non-invasive, somatosensory-based therapy method which hasproven effective in the treatment of anxiety related illness; themechanism of this therapy is thought to be the modulation of theelectrical activity of brain networks that mediate the stress responsewith some studies showing a 50%-62% reduction in stress related symptomsafter treatment (Serin, Hageman and Kade, 2018). The treatment isadministered by the use of a device which produces left-rightalternating vibrotactile stimulation via two vibrating pods or “paddles”which are held by the patient. Currently, several BLS devices arecommercially available; the devices marketed to practitioners havecorded pods (held by the patient) connected to a battery-powered controlbox (held by the therapist) which has adjustment knobs for amplitude,frequency, and in some cases, volume controls for audio synchronizationoutput to a headphone jack. There is also a similar market for personaluse devices, mainly for stress management; these personal devices areoften wearable wristbands that have integral rechargeable batteries andsynchronize wirelessly with a smartphone application that providesseveral standard treatment routines. For either form the retail pricepoint is between $160-180 however some with “advanced features” arepriced up to $300.

One device for inducing alternating tactile simulations in a humansubject was proposed in U.S. Pat. No. 6,001,073 issued to Schmidt et al.Dec. 14, 1989. That device includes a first vibrating element and asecond vibrating element connected to a controller. The subject holdsthe first vibrating element in one hand and the second vibrating elementin the other hand. When the device is activated the following occurs insequence: the first vibrating element vibrates, pauses, the secondvibrating element vibrates, pauses, the first vibrating elementvibrates, pauses, the second vibrating element vibrates, pauses, and soforth, until the device is deactivated.

Unfortunately, it has been found, that vibrating elements as used in theart often become irritating to the subject. Further, the availabledevices do not allow for use where the therapist and subject are indifferent locations remote from each other.

BRIEF SUMMARY OF THE DISCLOSURE

This summary is provided to introduce, in a simplified form, a selectionof concepts that are further described below in the DetailedDescription. This summary is not intended to identify key features ofthe claimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

One particularly distressing drawback of currently available systems isthat they do not provide a way for therapists to deliver bilateralalternating stimulation therapy over long distances and into remoteareas. Military personnel suffering with PTSD, for example, are oftenlocated in extreme environments, including militarized zones inundeveloped countries. It would be extremely beneficial for suchindividuals to avail themselves of therapy utilizing BLS type protocolsunder such conditions. This is one of the reasons that the inventorsherein have provided a new and novel remote control internet accessibletherapy system as described in the claims.

A bilateral alternating tactile stimulation therapeutic system thesystem includes an Internet web page; a first mobile device, at a firstlocation, configured to access the Internet web page, a first processor,onboard the first mobile device, the first processor being programmed toexecute a first application for transmitting audio information and pulsecontrol information including alternating pulsation signals foruploading to the Internet web page; a second mobile device, at a secondlocation remote from the first location, adapted to connect to theInternet web page; a second processor, onboard the second mobile device,programmed to execute a second application for receiving the audioinformation and the pulse control information in a streaming or livemode; a first pair of pulsating devices wirelessly coupled to the secondmobile device; and where the second processor is programmed to enable asubject to hear the audio information through the mobile device andtransmit the alternating pulsation signals to the pair of pulsatingdevices.

BRIEF DESCRIPTION OF THE DRAWINGS

While the novel features of certain embodiments of the invention are setforth with particularity in the appended claims, the invention, both asto organization and content, will be better understood and appreciated,along with other objects and features thereof, from the followingdetailed description taken in conjunction with the drawings, in which:

FIG. 1 schematically shows an example of a remotely controlled bilateralalternating tactile stimulation therapeutic system.

FIG. 2 schematically shows an example of a pulsating device as used in aremotely controlled bilateral alternating tactile stimulationtherapeutic system.

FIG. 3 schematically shows an example of a time sequence of pulses asused in a remotely controlled bilateral alternating tactile stimulationtherapeutic system.

FIG. 4 schematically shows an example of a process for uploading anddownloading a therapeutic session with control signals using a remotelycontrolled bilateral alternating tactile stimulation therapeutic system.

FIG. 5 schematically shows an example of an application control screenfor a therapist application for using a remotely controlled bilateralalternating tactile stimulation therapeutic system.

FIG. 6 schematically shows an example of an application control screenfor a subject application for using a remotely controlled bilateralalternating tactile stimulation therapeutic system.

FIG. 7 schematically shows an example of a pair of pulsating devicesserving as control units for transmitting pulse signals to a set ofadditional pulsating devices.

FIG. 8A and FIG. 8B are intended to be pieced together to functionallyshow an example of a motherboard circuit for controlling a pulsatingdevice.

FIG. 9 schematically shows an example of a process for live streaming atherapeutic session with control signals using a remotely controlledbilateral alternating tactile stimulation therapeutic system.

In the drawings, identical reference numbers identify similar elementsor components. The sizes and relative positions of elements in thedrawings are not necessarily drawn to scale. For example, the shapes ofvarious elements and angles are not drawn to scale, and some of theseelements are arbitrarily enlarged and positioned to improve drawinglegibility. Further, the particular shapes of the elements as drawn, arenot intended to convey any information regarding the actual shape of theparticular elements and have been solely selected for ease ofrecognition in the drawings.

DETAILED DESCRIPTION

The following disclosure describes a method and system for remotelycontrolled bilateral alternating tactile stimulation therapy. Severalfeatures of methods and systems in accordance with example embodimentsare set forth and described in the figures. It will be appreciated thatmethods and systems in accordance with other example embodiments caninclude additional procedures or features different than those shown inthe figures. Example embodiments are described herein with respect to amethod and system directed to an Internet based streaming of a recordedsession or a live streaming mode. However, it will be understood thatthese examples are for illustrating the principles, and that theinvention is not so limited.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, suchas, “comprises” and “comprising” are to be construed in an open,inclusive sense that is as “including, but not limited to.”

Reference throughout this specification to “one example,” “an exampleembodiment,” “one embodiment,” “an embodiment” or combinations and/orvariations of these terms means that a particular feature, structure orcharacteristic described in connection with the embodiment or example isincluded in at least one embodiment or example of the presentdisclosure. Thus, the appearances of the phrases “in one example” or “inan example” in various places throughout this specification are notnecessarily all referring to the same example embodiment or example.Furthermore, the particular features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments orexamples.

Definitions

Generally, as used herein, the following terms have the followingmeanings:

The articles “a” or “an” and the phrase “at least one” as used hereinrefers to one or more.

“Bluetooth®” technology, as used herein means a commercially availablelow-power wireless connectivity technology used to stream audio,transfer data and broadcast information between devices. Bluetooth®technology is a wireless technology standard for exchanging data betweenfixed and mobile devices over short distances using short-wavelength UHFradio waves in the industrial, scientific and medical radio bands, forexample, from 2.400 to 2.485 GHz. This technology is available fromBluetooth SIG, Inc. of Kirkland, Wash.

ANT is an ultra-low power (ULP) wireless networking protocol whichenables objects from everyday life to connect with each other similar toBluetooth® technology.

As used herein, “mobile device” has its generally accepted meaning andincludes any portable device that can make and receive telephone callsto and from a public telephone network, which includes cellulartelephones, and other mobile and fixed-line phones across the world. Italso includes mobile devices that support a wide variety of otherservices such as Voice over Internet Protocol (VOIP), text messaging,software applications, MMS, e-mail, Internet access, and short-rangewireless communications (for example, infrared and Bluetooth®communications).

As used herein, “tablet computer” has its generally accepted meaning andincludes any mobile computer including a complete mobile computer,larger than a mobile phone or personal digital assistant, integratedinto a flat touch screen and primarily operated by touching the screensuch as, for example, an Apple iPad® tablet computer.

As used herein, “plurality” is understood to mean more than one. Forexample, a plurality refers to at least 2, 3, 4, 5, 70, or more.

As used in this specification, the terms “computer”, “processor” and“computer processor” encompass a personal computer, a tablet computer, asmart phone, a microcontroller, a microprocessor, a field programmableobject array (FPOA), a digital signal processor (DSP), anapplication-specific integrated circuit (ASIC), a field programmablegate array (FPGA), a programmable logic array (PLA), or any otherdigital processing engine, device or equivalent capable of executingsoftware code including related memory devices, transmission devices,pointing devices, input/output devices, displays and equivalents.

As used herein “network” is understood to mean a digitaltelecommunications network which allows nodes to share resources and/ora computer network wherein computing devices exchange data with eachother using data link connections between nodes. Typically these datalinks are established over cable media such as wires or optic cables, orwireless media such as Wi-Fi.

As used herein, the “Internet” is a computer network providing access tothe World Wide Web, digital video, digital audio, shared use ofapplication and storage servers, printers, and fax machines, and use ofemail and instant messaging applications as well as many others.

“Obtaining” is understood herein as manufacturing, purchasing, orotherwise coming into possession of.

As used herein “remote” is understood as meaning separated by a distancebeyond the typical range of a fixed location Bluetooth® signal, in adifferent building, in a different country or out of the line of sightof a selected mobile device.

Example Embodiments

The remotely controlled bilateral alternating tactile stimulationtherapeutic system disclosed herein has several advantages over knownsystems. For the first time, it enables a therapist to live stream atherapy session including alternating tactile bilateral stimulation to asubject over the Internet so that the therapist and subject need not bein the same room or even in the same country. In another advantage, thedisclosed system and method enables a subject to download a prerecordedtherapy session into a mobile device, allowing the subject toself-conducted therapy session when unable to access the Internet.

Referring now to FIG. 1, an example of a remotely controlled bilateralalternating tactile stimulation therapeutic system is schematicallyshown. A bilateral alternating tactile stimulation therapeutic system 10includes a first mobile device 12, a second mobile device 14, and a pairof pulsating devices 20. Each of the first and second mobile devices 12,14 are adapted to wirelessly couple to the Internet 16. Residing in theInternet 16 is a dedicated website 18. The website 18 may includecomputer software programs, typically called applications, which may beuploaded and downloaded through the first and second mobile devices 12,14 and other known systems or devices such as personal computers. Theapplications are described hereinbelow in relation to touchscreenactivation icons representing the various applications that are executedby an onboard processor.

In one useful example, a professional, such as a therapist, may downloada therapist application 22 from the website 18 to program an onboardprocessor 13A. A subject, such as a client of the therapist, using thesecond mobile device may download a subject application 24 from thewebsite 18 to program a second onboard processor 13B. The downloadedapplications reside in the first and second onboard processors 13A, 13Bso that the processors are programmed to allow interactions between thefirst and second mobile devices including voice and video communicationsand control signals for the pulsating devices, as explained in moredetail below.

In one example, the therapist application 22 programs the processor toprovide audio, video, and control signals to pulsating devices throughthe Internet website 18 as transmitted by the therapist. The subjectapplication 24 provides control signals for controlling atransmitter/receiver 25. Transmitter/receiver 25 receives radiofrequencycontrol signals from the Internet and transmits radiofrequency controlsignals, such as Bluetooth® generated signals, to the pair of pulsatingdevices 20. The system may be used by real-time streaming or livethrough the website or another communications website. In an alternateexample, the subject may download a pre-recorded session from thewebsite and play it whether or not connected to the Internet.

Referring now to FIG. 2, an example of a pulsating device as used in aremotely controlled bilateral alternating tactile stimulationtherapeutic system is schematically shown. Each pulsating device 20comprises a transmitter/receiver 32, a controller 34, a rechargeablebattery 38, a stimulation element 36 and a status light 40. Thetransmitter/receiver 32 may be a Bluetooth® transmitter/receiver, butmay also be another dedicated RF transmitter/receiver. The controller 34may comprise a microprocessor or the like programmed to receive signalsfrom the transmitter/receiver 32 and translate them into control signalsfor the stimulation element 36 and the indicator light 40. The battery38 is coupled to supply power to each of the components either directlyor through the controller 34. The battery 38 is advantageouslyrechargeable by connection to an electrical connector 43 which isadapted to accept, for example, a power cord such as a USB connector 42.When recharging, the USB connector may connect the battery to a powersource 44, such as a computer USB port or the like.

In one useful example the battery may comprise a rechargeablelithium-ion battery. The components may advantageously be mounted on amotherboard. A more detailed example of circuit components is describedbelow with reference to FIG. 8A and FIG. 8B. A shell or case 23 providesa housing for enclosing the motherboard. The case 23 may advantageouslybe contoured for ease of holding by a human hand.

In operation, the Bluetooth® transmitter/receiver 32 receives wirelesssignals 27 including control signals and passes them on to controller34. In response, the stimulation element 36 may be activated ordeactivated. Further, the indicator light 40 may be switched into aplurality of color modes such as red signifying “off,” yellow signifying“connecting,” and green signifying “connected” modes.

Referring now to FIG. 3, an example of a time sequence of pulses as usedin a remotely controlled bilateral alternating tactile stimulationtherapeutic system is schematically shown. In one example, a pulsecontrol signal 60 may be applied in an alternating fashion to each ofthe pulsating devices 20. The pulse control signal 60 may be carried bythe RF signal 27 and received by the pulsating devices 20. In operation,the pulsating signal 60 may alternate between 0 amplitude or “off” andamplitude A wherein a tactile pulse will be delivered to the subject.Amplitude A must be high enough to activate the stimulation element toproduce a tactile response that will be sensed by the subject, as forexample when holding a pulsating device 20 in hand, but not so high asto injure or be uncomfortable to the subject. The amplitude A, in oneexample, may be variably controlled by the therapist or the subjectthrough the applications residing in the mobile devices. It will beunderstood by those skilled in the art that this is merely one exampleof a pulse signal waveform and the invention is not so limited. Forexample, the time between pulses may be as short as 50 ms or as long as1000 ms or more depending on the response of the subject.

The control waveform 60 includes periodic peaks T₀, T₁, T₂, T₃, T₄ . . .T_(N) such that single pulse activation signals are delivered in analternating fashion to the pulsating devices 20 (where N represents aninteger number proportional to the length of time of a therapy session).For example, a pulsating device held in the right-hand may pulsateduring even subscripted times T₀, T₂, T₄ . . . etc. and be turned offduring the odd times. A second pulsating device held in the left-handmay pulsate during odd subscripted times T₁, T₃ . . . etc. and be turnedoff during pulses occurring at the even numbered times, thus supplyingalternating bilateral tactile stimulation to the subject. Those skilledin the art having the benefit of this disclosure will recognize thatother waveforms and vibration schemes may be used. In another example,the therapist may control the pulsating devices manually by activationicons on the mobile device application. In yet another example, thesubject may himself manually control the pulsating devices. Of course,the invention is not limited to single pulse stimuli and the pulsationdevices may also operate in other tactile stimulus modes includingvibrating at various frequencies.

Referring now to FIG. 4, an example of a process for uploading anddownloading a therapeutic session with control signals using a remotelycontrolled bilateral alternating tactile stimulation therapeutic systemis schematically shown. In some cases, it may not be possible for asubject to access the Internet as, for example, during a power outage orwhen the subject is in a very remote location. At the same time, suchcircumstances may cause a subject to experience severe anxiety thatwould be ameliorated by bilateral alternating tactile response therapy.Therefore, here provided is a process for storing a therapy session in awebsite or other processor or mobile device for delivering to thesubject as a self-contained therapy session. In this process, atherapist 100 may record a therapy session including synchronizedcontrol signals for operating pulsating devices at activity 70. Thecontrol signals are synchronized to an audio recording made by thetherapist. The recorded session may then be stored in a session file 72.The session file may then be uploaded to a website at activity 74,transmitted as a file to the subject at activity 76, directlytransmitted into the subject's mobile device at activity 78, ortransmitted using other means known in the art. For example, dependingon the size of the file and other factors the file may be transmitted byemail, file sharing protocols, cloud storage sharing or the like. Whenready, subject 200 may play the session file as indicated at activity80.

Referring now to FIG. 5, an example of an application control screen fora therapist application for using a remotely controlled bilateralalternating tactile stimulation therapeutic system is schematicallyshown. A screen 500 may present a plurality of touchscreen sensitiveregions represented by icons, text boxes or equivalents for accessingvarious features of the therapist application. The icons mayadvantageously include at least a control icon for accessing a controlprogram executed by a processor for recording a session withsynchronized control signals 502, an icon for uploading a session 504,an icon for accessing a program executed by a processor for activatingpulse signals 506, an icon for linking to a website 508, an icon foraccessing a program executed by a processor for transmitting a sessionfile to a subject 510, an icon for accessing a program executed by aprocessor for downloading a session file 512, an icon for accessing aprogram executed by a processor for playing a session file 520 and anicon for accessing a program executed by a processor for trackingprogress of at least one subject 522. Other common features may beincluded such as checking status messages, checking push notificationsand the like.

Referring now to FIG. 6, an example of an application control screen fora subject application for using a remotely controlled bilateralalternating tactile stimulation therapeutic system is schematicallyshown. As in the therapist application described above, a screen 600 maypresent a plurality of touchscreen sensitive regions or icons foraccessing various features of the therapist application. The icons mayadvantageously include at least an icon for accessing a program executedby a processor for downloading a session file 602, an icon for accessinga program executed by a processor for linking to a website 604, an iconfor accessing a program executed by a processor for activating pulsesignals 606, an icon for accessing a program executed by a processor forplaying a session file 608 and an icon for accessing a program executedby a processor for tracking progress of the subject 610. Other commonfeatures may be included such as checking status messages, checking pushnotifications and the like.

Referring now to FIG. 7, an example of a pair of pulsating devicesserving as control units for transmitting pulse signals to a set ofadditional pulsating devices is schematically shown. In this example,the therapist application 22 transmits pulse control signals 27A, 27B tobilaterally located primary pulsation devices 20A and 20B. Using, forexample, Bluetooth® technology, the primary pulsation devicessimultaneously transmit the received control signals 27A, 27B tosecondary sets of pulsating devices 20C-20F. In this way, a singletherapist may be able to conduct a group session using the therapistapplication 22 and the pulsating devices 20 in a single location.

Now referring jointly to FIG. 8A and FIG. 8B, the figures are intendedto be pieced together to functionally show an example of a motherboardcircuit for controlling a pulsating device. A motherboard 800A, 800Bincludes a capacitive proximity/touch sensor 802, a DC/DC converter 804,a Bluetooth®-compliant system-on-a-chip 806 (SoC), a haptic driver 808,and ERM motor 810, a fuel gauge circuit 812, a 3 channel CC LED driver814, and RGB LED 816, a cell protector 830, and ion battery 832 and abattery charger 834. The motherboard circuits are housed within andconnected to the shell and outputs of each of the pulsating devices 20.

Referring now more particularly to FIG. 8A, there are four mainfunctional subcircuits comprising the capacitive proximity/touch sensor802, stimulation subcircuit 910 comprising the haptic driver 808 andmotor 810, a status light subcircuit 915 comprising the 3 channel CC LEDdriver 814 an RGB LED 816, and a power subcircuit 905A, 905B includingthe battery charger 834, cell protector 830, battery 832, fuel gauge812, and nano power DC/DC converter 804. The subcircuits all receiveinformation from or supply information to and from theBluetooth®-compliant system-on-a-chip 806. The system-on-a-chip 806provides all of the executive functions including control signals to theother subcircuits. The executive functions may reside on the SoC assoftware applications onboard as firmware or software.

In one example, the power circuit 905A, 905B is electrically coupled tosupply power to each of the other subcircuits and the SoC 806. Thecapacitive proximity/touch sensor 802 is connected to receive power fromnano power DC/DC converter 804 through electrical connection 801 andcontrol signals from the SOC 806 through electrical connection 805. Thestimulation subcircuit 910 receives triggering signals throughelectrical connection INT/TRIG 809. In operation, INT/TRIG 809 transmitsinterrupts or trigger signals in the form of pulses as shown in FIG. 3received by the haptic driver 808. Electrical connection 811 may be aI2C (SDA/SCL) bus. I2C is a serial protocol for two-wire interface toconnect low-speed devices like microcontrollers, EEPROMs, A/D and D/Aconverters, I/O interfaces, and other similar peripherals in onboardsystems. An enable signal 817 may be transmitted through electricalconnection 817 from the SOC 806 to the haptic driver 808. Power isapplied to the haptic driver 808 from the DC/DC converter 804 throughelectrical power line 821.

The haptic driver 808 is connected to drive the ERM motor 810 or alinear resonant actuator (LRA), depending on the type of hapticstimulator employed, using electrical connections 813, 815. If an ERMmotor is used the haptic driver outputs DC signals, if an LRA is usedthe haptic driver outputs AC signals. The capacitive proximity touchsensor 802 is connected to transmit and receive electrical signals fromthe case electrode 820. The case electrode 820 is part of the case of astimulation device 20. The status light indicator subcircuit 915includes the 3 channel CC LED driver 814 which is connected by powerline829 to the fuel gauge circuit 812. RGB LED receives red, green, and bluesignal information from the LED driver 14 BR electrical connections 835,837, and 839, respectively. Power to the RGB LED 816 is routed throughelectrical connection 843. Control signals are supplied by SOC 806through electrical connection 811 to the 3 channel CC LED driver 814.

Referring now particularly to FIG. 8B, a second portion of the powercircuit 905B includes the cell protector 830, battery 832, and thebattery charger 834. In one example, the battery charger 834 may receivea charge from and external USB port 840 connected to or part of apersonal computer, battery charger or the like. Battery charger 834receives charging information from the nano power DC/DC converter 804and the fuel gauge 812 through electrical connections 825, 827. In oneexample, line 825 may be a ground which is applied by connection 851 tocell protector 830 and 825 to the battery charger 824. The battery 832is connected to fuel gauge circuit 812 by a positive terminal connection831. The battery 832 is also connected electrically to cell protector830 by electrical connection 853.

Motherboard Example SoC:

One example embodiment was built around the system-on-a-chip 806 wherethe selected SoC was a Nordic Semiconductor model number nRF52832. ThenRF52 series supports Bluetooth® standards BLE5.0 as well asBLE4.2/4.1/4.0 and ANT protocols and has an ARM Cortex M4F processor at64 Mhz. Additionally, the nRF52832 has an onboard NFC Class-A tag whichcan be programmed by the device, a feature which is useful for pairingtechniques such as out of band pairing (OOB), or for conveying deviceinformation such as serial and model numbers, as well as, firmwareinformation such as build version or mesh address.

The battery selected was a coin cell rechargeable lithium battery. TheRJD2032C1 is a CR2032 form factor Lithium nickel manganese cobalt oxide(Li-NMC) cell with a rated capacity of 85 mAh and a nominal voltage of3.7V. A brief charge time was a desirable feature and since this batteryis designed to charge at 0.5 C or 40 mA, this met the desired parameterswith a charge time of approximately two hours. The RJD2032 isspecifically designed for wearables and IoT devices and isUL1642-MH28281 certified for safety.

Battery Charging:

Battery charging was designed to be accomplished using a linear constantcurrent/constant voltage charger IC which includes automatic chargetermination (1/10 IC) and over temperature protection. The chargecurrent is programmed using a resistor, the device is set at 40 mA usinga 25 kOhm resistor. Charge status is indicated by a red charging LEDthat turns off after charge is terminated and the charge is supplied as5 volts from the micro usb charge port on the device.

Battery Monitoring:

As the device is wireless and battery powered, battery monitoring helpsassure system reliability. Additionally, battery status monitoring istypically considered standard with modern devices. To achieve betterperformance a commercially available fuel gauge integrated circuit (IC)was used (Maxim Integrated MAX17055). The fuel gauge IC employs acombination of voltage measurement and coulomb counting to provide amore accurate battery measurement. The MAX17055 employs a learningalgorithm to characterize the battery on the fly; this algorithmimproves characterization with each charge-discharge cycle of thebattery and can adapt the algorithm as the battery ages or is replaced.The fuel gauge provides common battery metrics such as state of charge,voltage, current and active power, and also time-to-empty andtime-to-full predictions and temperature.

Bus Power Regulator:

The SoC, as well as several peripherals on the device, have maximuminput voltages of 3.6v and so, since a fully charged lithium ion cellhas a voltage of 4.2-4.4v, a voltage regulator is required. The DC-DCconverter selected for this device was Texas Instruments model numberTPS82740A, a fully integrated power converter micromodule capable ofstable operation with no external components. The TPS82740 improveslight load efficiency with a PWM/PFM hybrid operating model: at heavyloads the converter operates on pulse width modulation (PWM) incontinuous conduction mode (CCM) and at light loads the converteroperates on pulse frequency modulation (PFM) in discontinuous conductionmode (DCM) which greatly reduces switching frequency and thus quiescentcurrent, allowing the converter to operate above 90% efficiency from 10pA-200 mA. This is a substantial improvement over a fixed 43% efficiencywith a linear regulator. The integrated micromodule results in a netreduction of components as the alternative LDO regulators require inputand output capacitors for stability.

Led Indicator:

In one example, the RGB status light 816 used was approximately ⅛″ indiameter; a 3528 LED with a diffuse lens was selected for improvedaesthetics. The three channel cc LED driver selected was an ISSI® modelIS31FL3193D integrated circuit. This IC prevents chromaticity andbrightness shifts due to battery voltage and also allows for patterneffects such as “breathing”, “color fading” and flashing to be scriptedon the driver IC, thereby reducing CPU workload. Additionally, thisselection reduced component count by five over discretetransistor/resistor solutions and allows for five programmablereferences current bands (5-42 mA), such that brightness can be adjustedwithout dithering color depth. Each channel has 8-bit current control,allowing for full 24-bit color at five brightness levels.

Touch Sensing:

In contrast to most current BLS systems that rely on mechanical powerswitches, the system disclosed herein provides a sleeker and more moderndevice appearance and interactivity. The sensor selected for the devicewas an Azoteq IQS231A single channel self-capacitance controller. It isconfigured for a sample rate of 4 sps but can be reconfigured, viasoftware, up to 100 sps (at higher power consumption). The theoreticalpower consumption is 9-12.5 μW (depending on bus voltage setting) at the4 sps sample rate.

Haptic Actuator:

The current BLS products on the market rely on eccentric rotating mass(ERM) type vibration actuators. ERM actuators are a proven technologywith simple control systems, but have substantial negatives: they aremechanically complex with many points of failure and have consumablecomponents (such as brushes and bearings) that greatly limit theeffective service life and cause increased noise and power consumption.The simulation device 20, in contrast to the state-of-the-art, useslinear resonant actuators (LRAs) which are mechanically much simpler,consisting of only of a coil, a spring, and magnet mass. As a result oftheir mechanical simplicity they have much longer or, in some cases,virtually infinite service lives and are also significantly more energyefficient than ERMs. The range of haptic effects that can be producedwith LRAs is much wider than ERMs since they are electrically. ratherthan mechanically, commutated.

Haptic Controller:

Since ERM actuators require a simple constant DC input and do notrequire polarity reversal, they can be controlled with a singletransistor. In contrast, LRAs require AC drive, a minimum of 4transistors in an H-Bridge configuration are needed to operate thedevice; additionally, this is complicated by the high Q factor of LRAs,often having an operating bandwidth of only a few hundred millihertz andso a control system must have very precise timing to effectively drivean LRA. To accomplish this with a minimum number of parts, a highlyintegrated haptic driver IC was selected. There are two common hapticdriver chips for LRAs; TI's DRV2605 and Dialog Semi's DA7280; the DA7280was initially chosen due to manufacturing constraints as the systemplanned for printing PCBs had a minimum allowable pad pitch of 0.65 mmand the DRV2605 is only offered in MSOP-10 (e=0.5 mm) or WLCSP-9 (e=0.4mm), while the DA7280 was offered in QFN-12 (e=0.65 mm) and WLCSP-9(e=0.4 mm). However, after close comparison it became evident that theDA7280 offered significant advantages over the drv26051. The sleepcurrent of the DA7280 is over an order of magnitude lower than that ofthe drv2605 (360 nA vs. 4.1 pA) and the DA7280 has a programablewaveform library, whereas the drv2605 has only the pre-loaded effectslibrary. Additionally, the DA7280 allows for more comprehensivediagnostics for both actuator and system.

Programming

In one example, a smartphone application was written in Ionic codinglanguage that offers a cross platform framework, reducing developmenttime and creating a consistent user interface for both Android and iOS.Google Firebase was selected as the web technology as its pricingstructure is favorable for a small user base, and it interfaces wellwith Ionic, allows cross registration to support multiple accounts andallows for https—supporting secure HIPAA compliant communication. Oneskilled in the art having the benefit of this disclosure and instructedby the functional description described herein would be able to prepareany required software programs using available technology and know-how.The programs are accessed by activating the touchscreen icons ortextboxes as described above.

Referring now to FIG. 9, an example of a process for live streaming atherapeutic session with control signals using a remotely controlledbilateral alternating tactile stimulation therapeutic system isschematically shown. The process includes beginning a session by openinga live session application 970. A live session application 970 residesin the mobile device or may be accessed through the website. A link tothe website is established at 972. Once the link to the website isestablished a therapist 100 may both communicate with the subject byaudio or video communications and also send BLS signals as needed. Thesubject 200 will, when the live session begins, open live sessionapplication 978 residing in the subject's mobile device or access by themobile device in the website through a link established at 980. Thesubject 200 then receives and transmits communications and receives BLSsignals as the session progresses 985.

In one example of a bilateral alternating tactile stimulationtherapeutic system the system includes an Internet web page; a firstmobile device, at a first location, configured to access the Internetweb page, a first processor, onboard the first mobile device, the firstprocessor being programmed to execute a first application fortransmitting audio information and pulse control information includingalternating pulsation signals for uploading to the Internet web page; asecond mobile device, at a second location remote from the firstlocation, adapted to connect to the Internet web page; a secondprocessor, onboard the second mobile device, programmed to execute asecond application for receiving the audio information and the pulsecontrol information in a streaming or live mode; a first pair ofpulsating devices wirelessly coupled to the second mobile device; andwhere the second processor is programmed to enable a subject to hear theaudio information through the mobile device and transmit the alternatingpulsation signals to the pair of pulsating devices.

In another example, the Internet web page includes computer softwareprograms for uploading and downloading.

In another example, the audio information and pulse control informationare transmitted using radio frequency signals.

In another example, the pair of pulsating devices include a receiver, acontroller electrically coupled to the receiver; a rechargeable batteryelectrically coupled to the controller and the receiver; a stimulationelement electrically coupled to the controller and the rechargeablebattery; and a status light electrically coupled to the controller andthe rechargeable battery.

In another example, the controller comprises a microprocessor orsystem-on-a-chip.

In another example, the status light emanates a plurality of colormodes.

In another example, the pulse control information comprises a timesequence of pulses.

In another example, the first mobile device has an application controlscreen for a therapist application for using a remotely controlledbilateral alternating tactile stimulation therapeutic system comprisinga control icon for recording a session with synchronized controlsignals; an upload icon for uploading a session; an activation icon foractivating pulse signals; a linking icon for linking to a website; atransmission icon for transmitting a session file to a subject; adownload icon for downloading a session file; a play icon for playing asession file; and a tracking icon for tracking progress of at least onesubject.

In yet another example, the second mobile device has an applicationcontrol screen for a subject application for using a remotely controlledbilateral alternating tactile stimulation therapeutic system comprisinga linking icon for linking to a website; a download icon for downloadinga session file; a play icon for playing a session file;

and a tracking icon for tracking progress of the subject.

In another example, the system further includes a plurality ofadditional pairs of pulsating devices wirelessly coupled to the firstpair of pulsating devices.

In another example, a method for pre-recording and delivering atherapeutic session including audio information and control signalsincludes the acts of downloading a first bilateral alternating tactilestimulation therapeutic system application on a first mobile device;operating the first mobile device to execute the first application torecord a therapy session including audio information and synchronizedcontrol signals for operating pulsating devices; storing the recordedsession in a session file; uploading the session file to a website,transmitting the session file into another mobile device; downloading asecond bilateral alternating tactile stimulation therapeutic systemapplication on a second mobile device; receiving the session filethrough the second application in the second mobile device; operatingthe second application to play the session file on the second mobiledevice to listen to the audio information; and wirelessly controlling afirst pair of pulsating devices with the synchronized control signals.

In another example, the method further includes wirelessly connecting atleast a second pair of pulsating devices to the first pair of pulsatingdevices; and controlling the at least second pair of pulsating devicesthrough the first pair of pulsating devices.

In another example a method for live streaming a therapeutic sessionincluding audio information and bilateral alternating tactilestimulation signals, where the method includes the acts of operating afirst mobile device to open a first live session application by atherapist; establishing a first link to a website; once the first linkto the website is established, communicating with a subject by audio orvideo communications; transmitting a series of BLS signals by thetherapist; opening a second live session application; establishing asecond link to the website; receiving and transmitting communications bythe subject; and receiving the BLS signals by the subject through thesubject's mobile device.

In another example the first live session application resides in thefirst mobile device or may be accessed through the website.

In yet another example, the second live session application resides inthe subject's mobile device or is accessed by the subject's mobiledevice in the website established through the second link.

Certain exemplary embodiments of the invention have been describedherein in considerable detail in order to comply with the PatentStatutes and to provide those skilled in the art with the informationneeded to apply the novel principles of the present invention, and toconstruct and use such exemplary and specialized components as arerequired. However, it is to be understood that the invention may becarried out by different equipment, and devices, and that variousmodifications, both as to the equipment details and operatingprocedures, may be accomplished without departing from the true spiritand scope of the present invention.

REFERENCES

The teachings of the following publications are incorporated byreference herein.

-   1. Amano, T., & Toichi, M. (2016). The Role of Alternating Bilateral    Stimulation in Establishing Positive Cognition in EMDR Therapy: A    Multi-Channel Near-Infrared Spectroscopy Study. PloS one, 11(10),    e0162735. doi:10.1371/journal.pone.0162735-   2. Bandelow, B., & Michaelis, S. (2015). Epidemiology of anxiety    disorders in the 21st century. Dialogues in clinical neuroscience,    17(3), 327-335.-   3. Bisson J, Ehlers A, Matthews R, Pilling S, Richards D, Turner S.    Psychological treatments for chronic post-traumatic stress disorder:    Systematic review and meta-analysis. British Journal of Psychiatry.    2007; 190: 97-104. 10.1192/bjp.bp.106.021402-   4. Ohira H, Nomura M, Ichikawa N, Isowa T, Iidaka T, Sato A, et al.    Association of neural and physiological responses during voluntary    emotion suppression. Neuro Image. 2006; 29-3: 721-733.    10.1016/j.neuroimage.2005.08.047-   5. Serin A., Hageman N, Kade E, The Therapeutic Effect of Bilateral    Alternating Stimulation Tactile Form Technology on the Stress    Response. Journal of Biotechnology and Biomedical Science    2018-1(2):42-47.

1. A bilateral alternating tactile stimulation therapeutic systemcomprising: an Internet web page; a first mobile device, at a firstlocation, configured to access the Internet web page; a first processor,onboard the first mobile device, the first processor being programmed toexecute a first application for transmitting audio information and pulsecontrol information including alternating pulsation signals foruploading to the Internet web page; the first processor being programmedto execute an application that records a therapy session, where thetherapy session is synchronized with the alternating pulsation signals;a second mobile device, at a second location remote from the firstlocation, adapted to connect to the Internet web page; a secondprocessor, onboard the second mobile device, programmed to execute asecond application for receiving the audio information and the pulsecontrol information in a streaming mode; a first pair of pulsatingdevices wirelessly coupled to the second mobile device; and where thesecond processor is programmed to enable a subject to hear the audioinformation through the mobile device and transmit the alternatingpulsation signals to the pair of pulsating devices.
 2. The system ofclaim 1 wherein the Internet web page includes computer softwareprograms for uploading and downloading.
 3. The system of claim 1 whereinthe audio information and pulse control information are transmittedusing radio frequency signals.
 4. The system of claim 1 wherein the pairof pulsating devices comprise: a receiver; a controller electricallycoupled to the receiver; a rechargeable battery electrically coupled tothe controller and the receiver; a stimulation element electricallycoupled to the controller and the rechargeable battery; and a statuslight electrically coupled to the controller and the rechargeablebattery.
 5. The system of claim 4 wherein the controller comprises amicroprocessor or system-on-a-chip.
 6. The system of claim 4 wherein thestatus light emanates a plurality of color modes.
 7. The system of claim1 wherein the pulse control information comprises a time sequence ofpulses.
 8. The system of claim 1 wherein the first mobile device has anapplication control screen for a therapist application for using aremotely controlled bilateral alternating tactile stimulationtherapeutic system comprising: a control icon for accessing a recordingapplication executed by the first processor to record the therapysession synchronized with the alternating pulsation signals; an uploadicon for accessing an upload application executed by the first processorto upload a session; an activation icon for accessing an activationapplication executed by the first processor to activate the alternatingpulsation signals; a first linking icon for accessing linking to awebsite; a transmission icon for accessing a transmitting programexecuted by the first processor to transmit a session file to a subject;a first download icon for accessing a first downloading program executedby the first processor to download a session file; a first play icon foraccessing a first play program executed by the first processor to play asession file; and a first tracking icon for accessing a first trackingprogram executed by the first processor to track progress of at leastone subject.
 9. The system of claim 1 wherein the second mobile devicehas an application control screen for a subject application for using aremotely controlled bilateral alternating tactile stimulationtherapeutic system comprising: a second mobile device linking icon foraccessing linking to a website; a second mobile device download icon foraccessing a second mobile device downloading program executed by thesecond processor to download a session file; a second mobile device playicon for accessing a second mobile device play program executed by thesecond processor to play the recorded therapy session; and a secondmobile device tracking icon for accessing a second mobile devicetracking program executed by the second processor to track progress ofat least one subject.
 10. The system of claim 1 further comprising aplurality of additional pairs of pulsating devices wirelessly coupled tothe first pair of pulsating devices. 11-15. (canceled)
 16. A bilateralalternating tactile stimulation therapeutic system comprising: anInternet web page; a first mobile device, at a first location,configured to access the Internet web page; a first processor, onboardthe first mobile device, the first processor being programmed to executea first application for transmitting audio information and pulse controlinformation including alternating pulsation signals for uploading to theInternet web page; a second mobile device, at a second location remotefrom the first location, adapted to connect to the Internet web page; asecond processor, onboard the second mobile device, programmed toexecute a second application for receiving the audio information and thepulse control information in a streaming or live mode; a first pair ofpulsating devices wirelessly coupled to the second mobile device; wherethe second processor is programmed to enable a subject to hear the audioinformation through the mobile device and transmit the alternatingpulsation signals to the pair of pulsating devices; and wherein thefirst mobile device has an application control screen for a therapistapplication for using a remotely controlled bilateral alternatingtactile stimulation therapeutic system including a control icon foraccessing a recording application executed by the first processor torecord a session with synchronized control signals; an upload icon foraccessing an upload application executed by the first processor toupload a session, an activation icon for accessing an activationapplication executed by the first processor to activate pulse signals, afirst linking icon for accessing linking to a website, a transmissionicon for accessing a transmitting program executed by the firstprocessor to transmit a session file to a subject, a first download iconfor accessing a first downloading program executed by the firstprocessor to download a session file, a first play icon for accessing afirst play program executed by the first processor to play a sessionfile, and a first tracking icon for accessing a first tracking programexecuted by the first processor to track progress of at least onesubject.
 17. The system of claim 16 wherein the second mobile device hasan application control screen for a subject application for using aremotely controlled bilateral alternating tactile stimulationtherapeutic system comprising: a second mobile device linking icon foraccessing linking to a website; a second mobile device download icon foraccessing a second mobile device downloading program executed by thesecond processor to download a session file; a second mobile device playicon for accessing a second mobile device play program executed by thesecond processor to play the recorded therapy session; and a secondmobile device tracking icon for accessing a second mobile devicetracking program executed by the second processor to track progress ofat least one subject.
 18. The system of claim 16 further comprising aplurality of additional pairs of pulsating devices wirelessly coupled tothe first pair of pulsating devices.
 19. A bilateral alternating tactilestimulation therapeutic system comprising: an Internet web page; a firstmobile device, at a first location, configured to access the Internetweb page; a first processor, onboard the first mobile device, the firstprocessor being programmed to execute a first application fortransmitting audio information and pulse control information includingalternating pulsation signals for uploading to the Internet web page; asecond mobile device, at a second location remote from the firstlocation, adapted to connect to the Internet web page; a secondprocessor, onboard the second mobile device, programmed to execute asecond application for receiving the audio information and the pulsecontrol information in a streaming or live mode; a first pair ofpulsating devices wirelessly coupled to the second mobile device; wherethe second processor is programmed to enable a subject to hear the audioinformation through the mobile device and transmit the alternatingpulsation signals to the pair of pulsating devices; and wherein thesecond mobile device has an application control screen for a subjectapplication for using a remotely controlled bilateral alternatingtactile stimulation therapeutic system including a second mobile devicelinking icon for accessing linking to a website, a second mobile devicedownload icon for accessing a second mobile device downloading programexecuted by the second processor to download a session file, a secondmobile device play icon for accessing a first second mobile device playprogram executed by the second processor to play the recorded therapysession, and a second mobile device tracking icon for accessing a secondmobile device tracking program executed by the second processor to trackprogress of at least one subject.
 20. The system of claim 19 furthercomprising a plurality of additional pairs of pulsating deviceswirelessly coupled to the first pair of pulsating devices.